Effectiveness of ATMX in Treating Adolescents With ADHD and SUD - Full Text View

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00218322

Purpose

Adolescents with attention deficit hyperactivity disorder (ADHD) often develop substance use disorders (SUD). The purpose of this study is to evaluate the effectiveness of atomoxetine in treating adolescents dually diagnosed with ADHD and SUD.

Condition	Intervention	Phase
Attention Deficit Disorder With Hyperactivity Substance-Related Disorders	Drug: Atomoxetine hydrochloride Drug: Placebo	Phase IV

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Atomoxetine Atomoxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Atomoxetine in Adolescents With Attention Deficit Hyperactivity Disorder (ADHD) and Substance Use Disorder (SUD)

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Symptoms of ADHD and SUD (measured at Week 12) [ Time Frame: 12 Weeks (LOCF) ] [ Designated as safety issue: No ]

Estimated Enrollment:	108
Study Start Date:	September 2004
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Treatment with placebo or atomoxetine for 12 weeks.	Drug: Placebo Placebo up to maximum dose of 40 to 100mg/day in daily dosing based on body weight up to 12 weeks of the study.
2: Experimental	Drug: Atomoxetine hydrochloride Atomoxetine up to maximum dose of 40 to 100mg/day in daily dosing based on body weight up to 12 weeks of the study.

Detailed Description:

High rates of ADHD have been reported in adolescents with SUD. In addition, untreated ADHD is a risk factor for developing SUD. Atomoxetine is a norepinephrine reuptake inhibitor, and is currently used to treat adolescents with ADHD. The purpose of this trial is to evaluate the efficacy of atomoxetine in treating adolescents dually diagnosed with ADHD and SUD.

This study will last up to 18 weeks. Participants will receive six treatments of manual-driven, cognitive behavioral therapy for substance abuse over at 6 or earlier weeks. Participants and their parents will partake in therapy sessions. Subjects who have completed at least 2 weeks of CBT will be eligible to enter the controlled trial, at which point participants will be randomly assigned to receive either atomoxetine or placebo, which they will take once daily for 12 weeks. At the Week 12 study visit, participants will be assessed for symptoms of ADHD and SUD.

Eligibility

Ages Eligible for Study:	15 Years to 30 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

DSM-IV diagnosis of ADHD
Current or recent (within the three months prior to study entry) SUD, including marijuana and alcohol abuse
ADHD CGI-S score of greater to or equal to 4

Exclusion Criteria:

Any Unstable medical condition
Recent history of intravenous drug use or cocaine dependence
Currently abusing ecstasy, cocaine, gamma-hydroxybutyrate, methamphetamine, amphetamine, opioids, phencyclidine, or benzodiazepine
Mental retardation or organic brain syndrome
Currently psychotic or history of bipolar disorder
Currently taking any psychotropic or anti-substance abuse disorder medications
Current DSM-IV diagnosis of major depression, depressive disorder, or anorexia
Pregnant or breastfeeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218322

Contacts

Contact: Kerry V. Brodziak, BA

617-503-1043

kbrodziak@partners.org

Locations

United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Kerry V. Brodziak, BA 617-503-1043 kbrodziak@partners.org

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Timothy E. Wilens

Massachusetts General Hospital

More Information

Responsible Party:	The Massachusetts General Hospital ( Timothy Wilens, M.D./Director of Substance Abuse )
Study ID Numbers:	NIDA-16264-1, K24-16264-1, DPMC
Study First Received:	September 16, 2005
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00218322
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Signs and Symptoms
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Substance-Related Disorders
Atomoxetine

Neurologic Manifestations
Disorders of Environmental Origin
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action

Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Nervous System Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009